Trial Outcomes & Findings for Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations (NCT NCT04120363)
NCT ID: NCT04120363
Last Updated: 2022-10-07
Results Overview
A load carriage time trial (a militarily relevant aerobic performance assessment) was conducted near the end of each study phase to assess aerobic performance.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
Day 5 (Phase 1), Day 26 (Phase 2), Day 47 (Phase 3)
Results posted on
2022-10-07
Participant Flow
Participant milestones
| Measure |
Testosterone
single intramuscular injection of 750 mg testosterone undecanoate on Day 8
Testosterone Undecanoate: single intramuscular injection of 750 mg testosterone undecanoate
|
Placebo
single intramuscular injection of 750 mg sesame oil solution on Day 8
Sesame Oil: single intramuscular injection of 750 mg sesame oil solution
|
|---|---|---|
|
Phase 1
STARTED
|
16
|
18
|
|
Phase 1
COMPLETED
|
16
|
18
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
|
Phase 2
STARTED
|
16
|
18
|
|
Phase 2
COMPLETED
|
16
|
16
|
|
Phase 2
NOT COMPLETED
|
0
|
2
|
|
Phase 3
STARTED
|
16
|
16
|
|
Phase 3
COMPLETED
|
16
|
16
|
|
Phase 3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations
Baseline characteristics by cohort
| Measure |
Testosterone
n=16 Participants
single intramuscular injection of 750 mg testosterone undecanoate on Day 8
Testosterone Undecanoate: single intramuscular injection of 750 mg testosterone undecanoate
|
Placebo
n=18 Participants
single intramuscular injection of 750 mg sesame oil solution on Day 8
Sesame Oil: single intramuscular injection of 750 mg sesame oil solution
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.9 years
STANDARD_DEVIATION 4.4 • n=99 Participants
|
26.2 years
STANDARD_DEVIATION 4.5 • n=107 Participants
|
26.5 years
STANDARD_DEVIATION 4.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Body Mass
|
76.5 kg
STANDARD_DEVIATION 14.7 • n=99 Participants
|
77.5 kg
STANDARD_DEVIATION 10.2 • n=107 Participants
|
77.1 kg
STANDARD_DEVIATION 12.3 • n=206 Participants
|
|
Height
|
177.1 cm
STANDARD_DEVIATION 8.1 • n=99 Participants
|
176.3 cm
STANDARD_DEVIATION 5.3 • n=107 Participants
|
176.7 cm
STANDARD_DEVIATION 6.7 • n=206 Participants
|
|
BMI
|
24.3 kg/m^2
STANDARD_DEVIATION 3.8 • n=99 Participants
|
24.9 kg/m^2
STANDARD_DEVIATION 2.7 • n=107 Participants
|
24.6 kg/m^2
STANDARD_DEVIATION 3.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: Day 5 (Phase 1), Day 26 (Phase 2), Day 47 (Phase 3)Population: 2 participants in the placebo group dropped out of the study during Phase 2
A load carriage time trial (a militarily relevant aerobic performance assessment) was conducted near the end of each study phase to assess aerobic performance.
Outcome measures
| Measure |
Testosterone
n=16 Participants
single intramuscular injection of 750 mg testosterone undecanoate on Day 8
Testosterone Undecanoate: single intramuscular injection of 750 mg testosterone undecanoate
|
Placebo
n=18 Participants
single intramuscular injection of 750 mg sesame oil solution on Day 8
Sesame Oil: single intramuscular injection of 750 mg sesame oil solution
|
|---|---|---|
|
Load Carriage Time
2.5 mile time, Phase 1
|
45.21 min
Standard Error 2.01
|
41.58 min
Standard Error 1.94
|
|
Load Carriage Time
2.5 mile time, Phase 2
|
50.95 min
Standard Error 2.01
|
47.15 min
Standard Error 1.99
|
|
Load Carriage Time
2.5 mile time, Phase 3
|
44.31 min
Standard Error 2.07
|
39.34 min
Standard Error 2.12
|
PRIMARY outcome
Timeframe: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)Population: 2 participants in the placebo group dropped out of the study during Phase 2
Lower-body peak power was assessed near the end of each phase using a vertical jump test.
Outcome measures
| Measure |
Testosterone
n=16 Participants
single intramuscular injection of 750 mg testosterone undecanoate on Day 8
Testosterone Undecanoate: single intramuscular injection of 750 mg testosterone undecanoate
|
Placebo
n=18 Participants
single intramuscular injection of 750 mg sesame oil solution on Day 8
Sesame Oil: single intramuscular injection of 750 mg sesame oil solution
|
|---|---|---|
|
Vertical Jump Height
Vertical Jump Height, Phase 1
|
54.5 cm
Standard Error 2.5
|
53.6 cm
Standard Error 2.4
|
|
Vertical Jump Height
Vertical Jump Height, Phase 2
|
49.1 cm
Standard Error 2.5
|
50.0 cm
Standard Error 2.5
|
|
Vertical Jump Height
Vertical Jump Height, Phase 3
|
54.0 cm
Standard Error 2.5
|
50.5 cm
Standard Error 2.5
|
PRIMARY outcome
Timeframe: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)Population: 2 participants in the placebo group dropped out of the study during Phase 2
A 3-repetition maximum deadlift assessed muscular strength, endurance, and explosive power near the end of each study phase.
Outcome measures
| Measure |
Testosterone
n=16 Participants
single intramuscular injection of 750 mg testosterone undecanoate on Day 8
Testosterone Undecanoate: single intramuscular injection of 750 mg testosterone undecanoate
|
Placebo
n=18 Participants
single intramuscular injection of 750 mg sesame oil solution on Day 8
Sesame Oil: single intramuscular injection of 750 mg sesame oil solution
|
|---|---|---|
|
Total Mass Lifted
Total Mass Lifted, Phase 1
|
127.4 kg
Standard Error 7.4
|
127.9 kg
Standard Error 7.0
|
|
Total Mass Lifted
Total Mass Lifted, Phase 2
|
122.7 kg
Standard Error 7.4
|
119.0 kg
Standard Error 7.2
|
|
Total Mass Lifted
Total Mass Lifted, Phase 3
|
126.7 kg
Standard Error 7.7
|
129.8 kg
Standard Error 7.2
|
PRIMARY outcome
Timeframe: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)Population: 2 participants in the placebo group dropped out of the study during Phase 2
Anaerobic capacity was assessed using a Wingate anaerobic cycle test near the end of each study phase.
Outcome measures
| Measure |
Testosterone
n=16 Participants
single intramuscular injection of 750 mg testosterone undecanoate on Day 8
Testosterone Undecanoate: single intramuscular injection of 750 mg testosterone undecanoate
|
Placebo
n=18 Participants
single intramuscular injection of 750 mg sesame oil solution on Day 8
Sesame Oil: single intramuscular injection of 750 mg sesame oil solution
|
|---|---|---|
|
Wingate Peak Power
Wingate peak power, absolute, Phase 1
|
879.4 W
Standard Error 49.6
|
837.8 W
Standard Error 49.6
|
|
Wingate Peak Power
Wingate peak power, absolute, Phase 2
|
753.8 W
Standard Error 49.6
|
736.0 W
Standard Error 49.6
|
|
Wingate Peak Power
Wingate peak power, absolute, Phase 3
|
821.8 W
Standard Error 49.6
|
790.8 W
Standard Error 49.6
|
PRIMARY outcome
Timeframe: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)Population: 2 participants in the placebo group dropped out of the study during Phase 2
Peak aerobic capacity was measured via treadmill VO2peak near the end of each study phase.
Outcome measures
| Measure |
Testosterone
n=16 Participants
single intramuscular injection of 750 mg testosterone undecanoate on Day 8
Testosterone Undecanoate: single intramuscular injection of 750 mg testosterone undecanoate
|
Placebo
n=18 Participants
single intramuscular injection of 750 mg sesame oil solution on Day 8
Sesame Oil: single intramuscular injection of 750 mg sesame oil solution
|
|---|---|---|
|
Peak Aerobic Capacity
VO2peak, absolute, Phase 2
|
3.13 L/min
Standard Error 0.15
|
3.20 L/min
Standard Error 0.14
|
|
Peak Aerobic Capacity
VO2peak, absolute, Phase 3
|
3.29 L/min
Standard Error 0.15
|
3.44 L/min
Standard Error 0.14
|
|
Peak Aerobic Capacity
VO2peak, absolute, Phase 1
|
3.22 L/min
Standard Error 0.15
|
3.28 L/min
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Day 7 (Phase 1), Day 28 (Phase 2), Day 49 (Phase 3)Population: 2 participants in the placebo group dropped out of the study during Phase 2
A four-compartment (4C) model factoring in body mass, body volume, total body water, and bone mineral content was used to calculate fat-free body mass and fat mass at the end of each study phase.
Outcome measures
| Measure |
Testosterone
n=16 Participants
single intramuscular injection of 750 mg testosterone undecanoate on Day 8
Testosterone Undecanoate: single intramuscular injection of 750 mg testosterone undecanoate
|
Placebo
n=18 Participants
single intramuscular injection of 750 mg sesame oil solution on Day 8
Sesame Oil: single intramuscular injection of 750 mg sesame oil solution
|
|---|---|---|
|
Body Composition
Fat-free Mass at end of Phase 1
|
59.2 kg
Standard Error 2.0
|
59.8 kg
Standard Error 2.1
|
|
Body Composition
Fat-free Mass at end of Phase 2
|
59.6 kg
Standard Error 2.0
|
57.9 kg
Standard Error 2.1
|
|
Body Composition
Fat-free Mass at end of Phase 3
|
59.5 kg
Standard Error 2.0
|
59.6 kg
Standard Error 2.1
|
|
Body Composition
Fat Mass at end of Phase 1
|
17.3 kg
Standard Error 1.5
|
17.5 kg
Standard Error 1.6
|
|
Body Composition
Fat Mass at end of Phase 2
|
13.0 kg
Standard Error 1.5
|
14.4 kg
Standard Error 1.6
|
|
Body Composition
Fat Mass at end of Phase 3
|
15.1 kg
Standard Error 1.5
|
15.5 kg
Standard Error 1.6
|
Adverse Events
Testosterone
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Testosterone
n=16 participants at risk
single intramuscular injection of 750 mg testosterone undecanoate on Day 8
Testosterone Undecanoate: single intramuscular injection of 750 mg testosterone undecanoate
|
Placebo
n=18 participants at risk
single intramuscular injection of 750 mg sesame oil solution on Day 8
Sesame Oil: single intramuscular injection of 750 mg sesame oil solution
|
|---|---|---|
|
Vascular disorders
Cardiovascular issues
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
5.6%
1/18 • Number of events 1 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
|
Skin and subcutaneous tissue disorders
Dermatologic issues
|
81.2%
13/16 • Number of events 25 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
77.8%
14/18 • Number of events 26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
|
Gastrointestinal disorders
Gastrointestinal issues
|
43.8%
7/16 • Number of events 9 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
16.7%
3/18 • Number of events 5 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
|
Renal and urinary disorders
Genitourinary issues
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
0.00%
0/18 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal issues
|
93.8%
15/16 • Number of events 54 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
88.9%
16/18 • Number of events 40 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
|
Nervous system disorders
Neurological issues
|
31.2%
5/16 • Number of events 7 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
22.2%
4/18 • Number of events 6 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
|
General disorders
Nonspecific issues
|
37.5%
6/16 • Number of events 8 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
27.8%
5/18 • Number of events 5 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
|
General disorders
Oral complaints
|
25.0%
4/16 • Number of events 4 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
11.1%
2/18 • Number of events 2 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory issues
|
31.2%
5/16 • Number of events 7 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
22.2%
4/18 • Number of events 4 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
|
General disorders
Special senses issues
|
18.8%
3/16 • Number of events 4 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
0.00%
0/18 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
|
Additional Information
Jennifer C Rood, PhD
Pennington Biomedical Research Center
Phone: 225-763-2524
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place